Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572163
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Clinical Validation Study of the Eximis CS Contained Segmentation System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Validation Study of the Eximis CS Contained Segmentation System
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System
Detailed Description:
This is a prospective multi-center single-arm study to confirm device safety and effectiveness when utilized for containment segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications
Eligible subjects who have signed an informed consent form ICF will be enrolled Subjects will be sequentially enrolled and assigned a study identification number Surgeons will also be assigned a unique number
Subjects will undergo the standard of care regarding all aspects of the pre-operative surgical and follow-up procedures The aspect unique to this study is the capture segmentation and extraction of the target tissue will utilize one integrated device the Eximis CS System which segments tissue via segmenting wires using RF energy The device is not intended to provide any therapeutic effect
All subjects will be followed for safety through a post-procedure follow-up visit that will occur at minimum 30 days and maximum 45 days post-operatively through the post-procedure follow-up visit
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Eligible subjects who have signed an informed consent form ICF will be enrolled Subjects will be sequentially enrolled and assigned a study identification number Surgeons will also be assigned a unique number
Subjects will undergo the standard of care regarding all aspects of the pre-operative surgical and follow-up procedures The aspect unique to this study is the capture segmentation and extraction of the target tissue will utilize one integrated device the Eximis CS System which segments tissue via segmenting wires using RF energy The device is not intended to provide any therapeutic effect
All subjects will be followed for safety through a post-procedure follow-up visit that will occur at minimum 30 days and maximum 45 days post-operatively through the post-procedure follow-up visit
has context menu
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None